Issues in the Regulation of Dietary Supplements
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0092-8615/2001 Copyright 0 2001 Drug Information Association Inc.
ISSUES IN THE REGULATION OF DIETARY SUPPLEMENTS QUINTON
BRYAN,PHARMDCANDIDATE
Butler University, Indianapolis, Indiana
LAURAK. COLEMAN, PHARMD Visiting Scientist. Eli Lilly and Co., Rockville, Maryland
STACYM. MEISBERGER, PHARMD Regulatory Liaison, Eli Lilly and Co.. Rockville, Maryland
THOMAS COPMANN, PHD Director. Regulatory Affairs, Eli Lilly and Co., Rockville, Maryland
Increasing use of dietary supplements in the United States has commanded attention to regulatory issues regarding these products. Prior to the Dietary Supplement Health and Education Act of 1994 (DSHEA),regulation of dietary supplements was a gray area-they were classified somewhere between food and drugs. Regulations governing the acceptable claims for dietary supplements were finalized in January 2000, yet many issues remain controversial concerning the questionable safety and eflcacy of these products. Premarketing approval based upon clinical trials is not required for dietary supplements, making it difficult to determine safety, efficacy. and potential drug interactions. Little is known about the use of dietary supplements in pregnancy or in pediatric populations. Many supplements do not have standards for quality. strength, and purity. These concerns, as well as others, must be addressed in order to provide patients with safe and effective dietary supplements that could be instrumental in preventing disease and promoting health. Key Words: Dietary supplement; DSHEA; Structurelfunction; Drug interactions; Pregnancy
IMAGINE THE FOLLOWING: A 67-year-old man, living on Social Security and Medicare and already taking severa1 prescription medications for various ailments, invests in a bottle of ginseng to “boost his memory,” A 33-Year-old woman takes a week-long
is based on a Poster presentation by Stacy Meisberger and Thomas Copmann presented at the DIA Annual Meeting, July 2000. San Diego, California. Reprint address: Stacy Meisberger, PhmD, 1700 Rockville Pike, Suite 450. Rockville, MD 20852.
regimen of echinacea to ward off a cold, not yet realizing that she is four weeks pregnant, or A 40-year old man with HIV takes St. John’s Wort because he is feeling depressed. What do these situations have in common? Each illustrates a case in which the use of a dietary suuulement may adversely affect a patient’s health, or the health of an unborn child. Due to the fact that dietary supplemerits are not regulated like drugs, little solid evidence is available about the effects of
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these products. Safety and efficacy issues could include, among others: interactions with other drugs, effects on a developing fetus, or whether the supplement really delivers the claim that the consumer paid for. The cases illustrated above are hypothetical, but it is very likely that similar situations are occurring frequently in the Uni
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